CagriSema in 2026: FDA Review, Trials and Timing
CagriSema (cagrilintide + semaglutide) in 2026: the December 2025 FDA filing, REDEFINE trial results, expected decision and why online versions are fake.
3 min read
Key takeaways
CagriSema combines the amylin analog cagrilintide with semaglutide in one weekly injection. Novo Nordisk filed it with the FDA on December 18, 2025 and expects a decision in Q4 2026. Until approval, it cannot legally be bought — anything sold online is not the real product.
CagriSema at a glance
| Generic name | cagrilintide + semaglutide |
|---|---|
| Made by | Novo Nordisk |
| Type | Amylin analog + GLP-1 receptor agonist combination |
| Form | Weekly injection |
| How often | Once weekly |
| United States | Not FDA-approved. Filed December 18, 2025; Novo Nordisk guides to an FDA decision in Q4 2026. |
| Canada | Not approved. |
How it works
Semaglutide acts on GLP-1 receptors; cagrilintide mimics amylin, another fullness hormone. Acting on both pathways is designed to reduce appetite more than either alone.
What the trials showed
In the phase 3 REDEFINE 1 trial in adults with obesity, average weight loss was around 20–23% after 68 weeks, depending on the analysis. Gastrointestinal side effects were the most common, as with other incretin medicines.
Timeline
- December 18, 2025: submitted to the FDA for chronic weight management.
- Q4 2026: decision expected, according to Novo Nordisk.
- Canada: not approved.
Avoid “research” CagriSema
Websites selling cagrilintide or CagriSema “for research” are not selling an approved medicine. The FDA has warned sellers of unapproved GLP-1 products. If you want access now, the only legal route is a registered clinical trial.
Frequently asked questions
When will CagriSema be available?
Only after FDA approval; Novo Nordisk expects a decision in Q4 2026, and launch would follow.
Will it be stronger than Wegovy?
Trial results suggest more average weight loss than semaglutide alone, but direct comparisons and the final label will decide.
Can I join a trial?
Search ClinicalTrials.gov for cagrilintide studies near you.
Keep reading
Sources
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General information based on the official label. It does not replace advice from your prescriber or pharmacist.